Bavarian Nordic Announces USD 100 Million Supply Contract for IMVAMUNE Smallpox Vaccine with the U.S. Government
(Thomson Reuters ONE) -
* New order affirms the U.S. Government commitment to freeze-dried IMVAMUNE
COPENHAGEN, Denmark, May 19, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
today announced that the Biomedical Advanced Research and Development Authority
(BARDA), a division of the U.S. Department of Health & Human Services, has
ordered a bulk supply of IMVAMUNE(®) non-replicating smallpox vaccine, valued at
USD 100 million.
Under this new order, Bavarian Nordic will manufacture and store a bulk supply
of IMVAMUNE. This bulk material can be converted into freeze-dried IMVAMUNE at a
later date, once the freeze-drying manufacturing process has been transferred to
a commercial line, and is approved by the U.S. authorities. This new bulk
vaccine order will be produced and revenue recognized in 2017. This order
follows a USD 133 million order for bulk IMVAMUNE in 2015 resulting in a total
current investment of USD 233 million to date. A contract for the eventual
delivery of finished product to the U.S. Government is still required prior to
determining a dose price of the freeze-dried formulation.
The freeze-dried version of IMVAMUNE is expected to reduce the life cycle
management costs based on a longer shelf life and will replace the liquid-frozen
version that is currently stockpiled in the U.S. Strategic National Stockpile
(SNS). The freeze-dried version is well positioned to fulfill the U.S.
Government's long-term requirements for sufficient non-replicating smallpox
vaccine to protect 66 million Americans, comprised of those individuals for
whom a replicating smallpox vaccine is not recommended and their household
contacts.
"We are pleased to announce our continued successful collaboration with the U.S.
government, specifically BARDA and the NIH. This additional order of IMVAMUNE
will ensure that the preparedness of the U.S. government and the protection of
its people will not wane," said Paul Chaplin, President & Chief Executive
Officer of Bavarian Nordic. "It has been investments like this by BARDA, and the
research at the NIH, which have allowed successful medical countermeasures to be
stockpiled."
Federal funding acknowledgements
Procurement and development of IMVAMUNE has been funded in whole or in part with
Federal funds from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority, under Contract
No. HHSO100200700034C.
The development of a freeze-dried formulation of IMVAMUNE has been funded in
whole or in part with Federal funds from the Office of the Assistant Secretary
for Preparedness and Response, Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201000011C.
About IMVAMUNE Smallpox Vaccine
IMVAMUNE is being developed as a smallpox vaccine for individuals for whom
traditional replicating vaccines are contraindicated, such as people with atopic
dermatitis (AD) and HIV. IMVAMUNE is the Company's most advanced commercial
program. Studies comprising more than 7,600 subjects, including people diagnosed
with AD or infected with HIV, demonstrate that IMVAMUNE has a favorable safety
profile. In 2013, the vaccine was approved in Canada under the trade name
IMVAMUNE and in the European Union under the trade name IMVANEX(®).
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development, manufacturing and commercialization of cancer immunotherapies and
vaccines for infectious diseases, based on the Company's live virus vaccine
platform. Through long-standing collaborations, including a collaboration with
the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for
infectious diseases, including the non-replicating smallpox vaccine,
IMVAMUNE(®), which is stockpiled for emergency use by the United States and
other governments. The vaccine is approved in the European Union (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are developing an Ebola vaccine regimen, which has been fast-tracked, with the
backing of worldwide health authorities. Additionally, in collaboration with the
National Cancer Institute, Bavarian Nordic has developed a portfolio of active
cancer immunotherapies, including PROSTVAC(®), which is currently in Phase 3
clinical development for the treatment of advanced prostate cancer. The company
has partnered with Bristol-Myers Squibb for the potential commercialization of
PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on
Twitter (at)bavariannordic.
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Company Announcement no. 16 / 2016
2016-16-en:
http://hugin.info/100065/R/2013331/746397.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
[HUG#2013331]
Unternehmensinformation / Kurzprofil:
Datum: 19.05.2016 - 07:30 Uhr
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News-ID 472191
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